CMS announces plan to ensure availability of new Alzheimer's drugs but stakeholders cry foul

Photo: FG Trade/Getty Images

The Centers for Medicare and Medicaid Services will cover the high cost of Alzheimer's drugs if the Food and Drug Administration grants traditional approval and when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry.

The caveat has at least two organizations protesting that CMS' new release on Alzheimer drug coverage makes treatment no more accessible than under the agency's current policy of covering the drugs only for those taking part in clinical trials.

PhRMA said, "Today, under the guise of a positive development, CMS released information on the creation of a nation-wide Medicare patient registry for certain new Alzheimer's medicines granted traditional FDA approval. The administration touted this as exciting news, as steps they are taking to ensure seniors can access these medicines. But they buried the lede. In reality, CMS is reaffirming their plan to severely restrict patient access to FDA-approved medicines, leaving in place barriers to potentially life changing treatment options for a devastating illness. Requiring use of a registry to receive these important treatment options significantly constrains access."

George Vradenburg, chair and co-founder of UsAgainstAlzheimer's said, "Patients should have access to drugs found by the FDA to be safe and effective. While we are encouraged to see CMS making statements that seem consistent with recent testimony from the Administrator that Medicare will not limit access to drugs with full FDA approval, today's announcement raises many questions. The news release is silent on some of the same issues that the original coverage with evidence development (CED) raised: Will rural communities and areas without large, urban hospital systems be included? Will minority populations and those without financial means have equitable access? What will be the burden on doctors and patients participating in registries? 
 
"All Medicare patients should receive coverage to label without restricting access based on where you live or who your doctor is," Vradenburg said. "In the end, CMS is still imposing a requirement on Alzheimer's patients that hasn't been required for anyone else who wants an FDA-approved drug."

The easiest way to clear up these questions, she said, is to eliminate CED requirements for drugs demonstrated in large clinical trials found by FDA to be safe and effective.

WHY THIS MATTERS

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will discuss the results of a confirmatory trial of the Eisai product Leqembi on Friday, June 9, with a potential decision on traditional approval possible within weeks, CMS said. 

Broader Medicare coverage would begin on the same day the FDA grants traditional approval, CMS said. 

Under CMS' current coverage policy, if FDA grants traditional approval to other drugs in this class they would also be eligible for broader coverage. Currently two drugs in this class have received accelerated approval from the FDA, but no product has received traditional approval.
 
"If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered," CMS Administrator Chiquita Brooks-LaSure said. 
 
Medicare will cover drugs with traditional FDA approval when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world and submit this evidence through a nationwide, CMS-facilitated portal.

CMS said this approach is consistent with its National Coverage Determination. To get Medicare coverage people will need to be enrolled in Medicare Part B;  be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer's disease; and have a qualified physician participating in a registry, with an appropriate clinical team and follow up care. 

Other registries for drugs that may slow the progression of Alzheimer's disease may become available in the coming weeks and months, CMS said. 
 
THE LARGER TREND

Coverage of new Alzheimer's drugs is expensive and CMS has said the benefits of treatment have yet to be showns.

The anti-dementia medication lecanemab, and its ancillary costs, could add $2 billion to $5 billion in annual Medicare spending, according to a research letter in JAMA Internal Medicine. 

Currently, the medication is covered only for patients who are enrolled in clinical trials.

Medicare annual spending on lecanemab's medication costs alone would place it among the most expensive Part B medications delivered in outpatient facilities, JAMA said.

Twitter: @SusanJMorse
Email the writer: SMorse@himss.org